Mycoplasma genitalium (MG) is a gram-negative bacterium that lacks a cell wall and lives on the surface and in the epithelial cells of the urinary and genital tracts of men and women. M. genitalium is a common cause of nongonococcal urethritis (NGU) in men and an increasingly recognized cause of cervicitis and pelvic inflammatory disease (PID) in women. A recent meta-analysis has shown that infection with M. genitalium was associated with an approximately two-fold increase in risk for cervicitis, pelvic inflammatory disease, preterm birth, spontaneous abortion, and infertility in women. The prevalence of M. genitalium in lower risk populations in both men and women has been reported to be approximately 1% to 3%. In higher risk populations, prevalence of 10% to 41% in men and 7.3% to 14% in women has been reported. The prevalence of M. genitalium in higher risk populations often exceeds that of Neisseria gonorrhoeae and is similar to the prevalence of Chlamydia trachomatis. M. genitalium infections largely go unrecognized, and infected individuals are either asymptomatic or have symptoms similar to those associated with other bacterial infections of the urogenital tract.
The diagnosis of M. genitalium infection has traditionally been culture of urogenital specimens but culture is insensitive and slow and may take up to 6 months to recover the organism. Nucleic acid amplification tests (NAATs) for the diagnosis of M. genitalium infection in the United States and Europe NAATs have been made available as Laboratory Developed Procedures (LDPs) and have been shown to have superior sensitivity compared to culture.
The Center for Disease Control (CDC) recommends that M. genitalium should be suspected in cases of persistent or recurrent urethritis and may be considered in persistent or recurrent cases of cervicitis and pelvic inflammatory disease (PID). The fact that M. genitalium is a slow-growing organism, culture is not readily available, slow and insensitive, NAATs are the preferred method for M. genitalium detection. In research settings, M. genitalium is diagnosed by NAAT testing of urine, urethral, vaginal, and cervical swabs and through endometrial biopsies, typically using in-house PCR or assays intended for research use only. Thus there is a need in the art for a quick and reliable method to specifically detect MG in a sensitive manner.